Operator’s Manual 2 - 1
2 System Overview
2.1 Intended Use
Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and
neonates.It is intended for use in ophthalmic, fetal, abdominal, pediatric, small organ (breast,
thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal
(conventional), musculo-skeletal (superficial), thoracic/pleural, cardiac adult, cardiac pediatric,
peripheral vessel and urology exams.
2.2 Contraindication
For FDA region: None.
For Canada region: Ophthalmic use is only permitted by probes with an ophthalmic indication.
2.3 Safety Classifications
• According to the type of protection against electric shock:
Class I equipment + internally powered equipment
• According to the degree of protection against electric shock:
Type-BF applied part
• According to the degree of protection against harmful ingress of water:
– The main unit is rated as IPX0
– The probes are rated as IPX7
– The foot switch (can be applied in the operating room) is rated as IPX8
– The power adapter is rated as IP22
• According to the disinfection and sterilization method(s) recommended by manufacturer:
Equipment with disinfection and sterilization method(s) recommended by manufacturer.
• According to the degree of safety of application in the presence of a FLAMMABLE
ANESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE
EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANESTHETIC
MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE
• According to the mode of operation:
Continuous operation
• According to the installation and use:
Portable equipment
Mobile equipment (when the system is installed on the mobile trolley)
• Does the equipment has any defibrillation-proof applied parts:
Non-defibrillation-proof applied part
• Permanently installed equipment or non-permanently installed equipment:
Non-permanently installed equipment
To Next Page
Loading...
Need help?
General
